Maintenance Zanzalintinib With Etoposide After HDCT in GCT
NCT06937866 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-11-21
Summary
This is an open label, single arm phase I/II trial of maintenance zanzalintinib in combination with oral etoposide in patients with relapsed GCT treated with HDCT and PBSCT with a safety lead-in cohort in patients with relapsed, refractory metastatic GCT.
Conditions
- Germ Cell Tumor
Interventions
- DRUG
-
Zanzalintinib
Two zanzalintinib doses of 40mg and 60mg. The initial starting dose of zanzalintinib will be 40mg. The patients will receive zanzalintinib orally daily continuously for 28 day cycles.
- DRUG
-
Etoposide Capsule
Oral daily for 21 days of each 28 day cycle.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Indiana University
lead OTHER
Principal Investigators
-
Jennifer King, MD · Indiana University Simon Comprehensive Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-12
- Primary Completion
- 2030-03-31
- Completion
- 2031-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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